The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

HIV Infections Clinical Trial

— SAFER  

Official title:

The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049176
• Other study ID #: A126763
• Secondary ID: K01MH100994
• Status: Completed
• Start date: March 13, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

Description:

The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research. In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners. Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission. This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 31, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

For all couples:

• Couple expresses a desire to conceive

• Sexually active (defined as having vaginal sex with one another at least 6 times in the past 3 months

• Willing to enter the study as a couple and intending to remain as a couple and have a sexual relationship for the next 12 months

• Willing to use at least one safer conception strategy

• For men, age =18 years. For women, age 18 - 35 years;

• Able and willing to provide written informed consent

For HIV-uninfected members of the couple

• HIV-negative based on parallel negative HIV rapid tests, both at study screening and enrollment visit

• Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance =60 mL/min

For HIV-infected members of the couple

• HIV-positive based on parallel positive HIV rapid tests, based on national algorithm

• No current AIDS-defining illness

Exclusion Criteria:

• Amenorrheic

• Currently pregnant

• Active and serious infections, including active tuberculosis infection; active clinically significant medical problems including cardiac disease, pulmonary disease, and previously diagnosed malignancy expected to require further treatment.

• History of infertility defined as a year or more of regular unprotected intercourse with current partner without pregnancy, or otherwise medically diagnosed infertility

• Currently on any concomitant medication that requires the participant to avoid use of PrEP

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• PrEP (Truvada)
oral, daily Truvada for HIV-negative participants
• Antiretrovirals
oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant

Procedure:
• Semen washing
collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination
• Artificial vaginal insemination
collection of semen from an HIV-negative man, followed by intravaginal insemination

Locations

Country	Name	City	State
Zimbabwe	UZCHS-UCSF CTRC Zengeza Clinical Research Site	Harare

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Gilead Sciences, National Institute of Mental Health (NIMH), UZ-UCSF Collaborative Research Programme

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of safer conception strategies	proportion of couples choosing the strategy	12 months
Primary	Acceptability of safer conception strategies	proportion of couples remaining on strategy; reports of satisfaction	12 months
Primary	Adherence to safer conception strategies	proportion of couples with high adherence to strategy	12 months
Secondary	Effectiveness of safer conception strategies on HIV prevention	incidence of HIV	12 months
Secondary	Effectiveness of safer conception strategies on achieving pregnancy	incidence of pregnancy	12 months
Secondary	costs of providing safer conception services	costs	12 months
Secondary	cost-effectiveness of safer conception strategies	model the cost effectiveness of various combinations of safer conception strategies	12 months